Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS). Recruitment status was Active, not recruiting

Sponsor:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.

The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.

The following parameters will be measured or calculated: maximal and minimal concentration (Cmax, Cmin), half life (t1/2), Aire Under the Curve (AUC), clearance and volume of distribution, for all antiretroviral (according to treatment arm : AZT, 3TC, LPV, ABC, EFV) and cotimoxazol.

Exclusion Criteria for randomisation at 12 months in the simplification phase:

virological failure after the first 12 months of antiretroviral treatment

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01127204

Locations

Burkina Faso

Service de maladies infectieuses - CHU Charles de Gaulle

Ouagadougou, Burkina Faso

Service de pédiatrie - CHU Yalgado Ouedraogo

Ouagadougou, Burkina Faso

Côte D'Ivoire

CEPREF

Abidjan, Côte D'Ivoire

FSU abobo-Avocatier

Abidjan, Côte D'Ivoire

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)